NIH Director’s Blog, 10 November 2015 In recent years, there’s been a lot of talk about…

The underrepresented in clinical trials: a US perspective

Pharmaphorum.com: Rebecca Budd, TrialAdvance, Inc.

Rebecca Budd shares her opinions on some of the reasons behind underrepresentation in clinical trials in the United States, from both a patient and a sponsor perspective. She also provides her thoughts on the future of clinical trials for the pharmaceutical industry, if they continue in the same way.

Twenty years ago, clinical trial participants in the United States were homogeneous. Participants were overwhelmingly males, and White males at that1. Times have changed – but only to some extent. Although clinical trials are more diverse now than ever before, there continues to be a significant gap in clinical trial participation by minority subpopulations in the US. This includes racial and ethnic minorities, women, children, and the elderly.

The globalization of clinical trials has contributed to greater diversity in clinical trial participants. But it is not helping the problem of underrepresentation in US trials. The Tufts Center for the Study of Drug Development estimates that nearly half of all FDA-regulated trials are conducted overseas – rising from only 14% in 1997 to 47% in 20092. With fewer trials being conducted in this country, the absolute number of US minority participants is not increasing, even if there is an increase in the percentage of minorities participating. Read More